510(k) K042237 ยท HRS Plate, Fixation, Bone
EBI PERIARTICULAR PLATING SYSTEM
| Applicant | Ebi, L.P., Parsippany NJ, US |
| Decision | Substantially Equivalent, Sep 16, 2004 |
| Received | Aug 18, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042237
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 22, 2009 | EBI, L.P. Bone Screw 5.5MM X 45MM Bone Screw Lck-Cann, Rx only
Biomet, 100 Interpace Parkway, Parsippany, NJ 070454
The screw devices are an internal fixation device intended to aid in the alignment and stabil Terminated |
HSB | None listed |
| Sep 22, 2009 | EBI, L.P. Bone Screw 5.5MM X 55MM Bone Screw Lck-Cann, Rx only
Biomet, 100 Interpace Parkway, Parsippany, NJ 070454
The screw devices are an internal fixation device intended to aid in the alignment and stabil Terminated |
HSB | None listed |
| Sep 22, 2009 | EBI, L.P. Bone Screw 5.5MM X 70MM Bone Screw Lck-Cann, Rx only
Biomet, 100 Interpace Parkway, Parsippany, NJ 070454
The screw devices are an internal fixation device intended to aid in the alignment and stabil Terminated |
HSB | None listed |
| Sep 22, 2009 | EBI, L.P. Bone Screw 4.5MM X 20MM Bone Screw Lock, Rx only
Biomet, 100 Interpace Parkway, Parsippany, NJ 070454
The screw devices are an internal fixation device intended to aid in the alignment and stabilizat Terminated |
HSB | None listed |
| Sep 22, 2009 | EBI, L.P. Bone Screw 4.5MM X 28MM Bone Screw Lock, Rx only
Biomet, 100 Interpace Parkway, Parsippany, NJ 070454
The screw devices are an internal fixation device intended to aid in the alignment and stabilizat Terminated |
HSB | None listed |
| Sep 22, 2009 | EBI, L.P. Bone Screw 4.5MM X 36MM Bone Screw Lock, Rx only
Biomet, 100 Interpace Parkway, Parsippany, NJ 070454
The screw devices are an internal fixation device intended to aid in the alignment and stabilizat Terminated |
HSB | None listed |
| Sep 22, 2009 | EBI, L.P. Bone Screw 4.5MM X 52MM Bone Screw Lck-Cann, Rx only
Biomet, 100 Interpace Parkway, Parsippany, NJ 070454
The screw devices are an internal fixation device intended to aid in the alignment and stabil Terminated |
HSB | None listed |
| Sep 22, 2009 | EBI, L.P. Bone Screw .5MM X 60MM Bone Screw Lock, Rx only
Biomet, 100 Interpace Parkway, Parsippany, NJ 070454
The screw devices are an internal fixation device intended to aid in the alignment and stabilizati Terminated |
HSB | None listed |
| Sep 22, 2009 | EBI, L.P. Bone Screw 4.5MM X 70MM Bone Screw Lock, Rx only
Biomet, 100 Interpace Parkway, Parsippany, NJ 070454
The screw devices are an internal fixation device intended to aid in the alignment and stabilizat Terminated |
HSB | None listed |
| Sep 22, 2009 | EBI, L.P. Bone Screw4.5MM X 95MM Bone Screw Lock, Rx only
Biomet, 100 Interpace Parkway, Parsippany, NJ 070454
The screw devices are an internal fixation device intended to aid in the alignment and stabilizati Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.